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Session 5B: Risk-Based Review
Session Chair(s)
Nirdosh Jagota, PhD
Managing Partner, GRQ Biotech Advisors LLC, United States
Patient confidence in the quality of a product relies on regulatory approval of a product registration, which in turn relies on a company’s effective demonstration and conveyance of control of the quality attributes of that product. Benefits of a product with respect to patient needs have to be appropriately balanced with management of risks and uncertainty. This session will focus on how quality attributes can be conveyed in a product registration to effectively demonstrate how quality attributes are controlled and managed and can be reviewed to provide confidence in the quality of a product.
Speaker(s)
Confidence in Quality: A Proposal to Unify Approaches to Risk-based Regulatory Review
Roger Nosal, PhD
Vice President, Head of Global CMC, Pfizer Inc, United States
Presentation Title - TBD
Diane J. Zezza
Vice President and Global Head, Regulatory CMC, Novartis Pharmaceuticals Corporation, United States
Integrated Quality Assessment: The How and What of One Quality Voice
Sarah Pope Miksinski, PhD
Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
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